Fred Fox's Biography

Fred Fox,
Ethicist,
BioMedical Research Institute -- BioMed IRB

Fred Fox was recruited to the BioMed IRB two decades ago because he was willing to volunteer his time supporting the ethical oversight of medical research, and, had a professional background in the overlap of research, medicine and law. The BioMed IRB is part of the BioMedical Research Institute of America, which was founded by volunteers from bioengineering, medicine and education in 1955. The BioMed IRB provides oversight, since 1980, for researchers outside of hospitals or academic systems. At the request of investigators, Fred Fox also chaired the Stem Cell Research Oversight (SCRO) panels for trailblazing sponsors in need of independent ethical oversight. Fred is a California attorney and was general counsel in past decades for developers of scientific instrumentation and providers of health care insurance products.

What the Patient Advocate, Competent Authority and SCRO must see in the Submittals from and Operations of the Stem Cell Investigator

Monday, 22 April 2013 at 13:15

Add to Calendar ▼2013-04-22 13:15:002013-04-22 14:15:00Europe/LondonWhat the Patient Advocate, Competent Authority and SCRO must see in the Submittals from and Operations of the Stem Cell InvestigatorClinical Translation of Stem Cells Summit in Palm Springs, CA, USAPalm Springs, CA, USASELECTBIOenquiries@selectbiosciences.com

This presentation is to point out the lessons that should have been learned from examining a series of seemingly unrelated ethical case studies, one on a state and academic coalition to promote core competencies in stem cell research, one on a private sector and academic coalition to oversee the ethics of stem cell research, and one from within an academic medical center sanctioned by the FDA for intentionally evading oversight. The participants in ethical controversies in the field of stem cell research are too often surprised to learn that the defense of claiming to be engaged in the practice of medicine does not work. Stem cell research has always faced funding constraints triggered by moral controversies that led to added layers of regulatory requirements. There is a layer of moral screening that some institutions include in ethical reviews. For example, most academic advocates reject entirely any role for moral screening of stem cell research and do so at peril of facing ultimate research sanctions. Unique in the world of oversight of medical research, there is a formal and quasi regulatory role for the patient advocate when the research includes stem cells. Also, the part of the FDA that regulates stem cell research, the Center for Biological Evaluation and Research, was silent until last year, allowing both intentional and unintentional misconduct to go unpunished from the FDA. Finally, the academic SCRO membership had a conflict of interest against enforcement of properly auditing stem cell research, so a pattern of relying on certifications without training or practices of audit has left the investigators without any solid foundation to address ethical challenges to their work.